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Electrical Nerve Block for Amputation Pain

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ClinicalTrials.gov Identifier: NCT02221934
Recruitment Status : Recruiting
First Posted : August 21, 2014
Last Update Posted : June 1, 2018
Sponsor:
Information provided by (Responsible Party):
Neuros Medical, Inc.

August 15, 2014
August 21, 2014
June 1, 2018
October 9, 2014
June 2020   (Final data collection date for primary outcome measure)
  • Primary Effectiveness Endpoint: Reduction of Pain Level by 50% from Baseline [ Time Frame: 3 months post implant ]
    Demonstration of 50% reduction in a Numerical Rating Scale (NRS) pain score from pre-treatment to post-treatment for more than 50% of all pain episodes. Study success will be determined by a superiority test on the difference between responder rates in the Test group (those receiving the treatment) and Control group (those who do not receive treatment).
  • Primary Safety Endpoint: Incidence of Reported and Adjudicated Serious Adverse Events [ Time Frame: From consent through 3 months post implant ]
    Incidence of all serious adverse events including serious adverse device events and unanticipated adverse device events.
  • Pain reduction after each treatment session as measured by Numerical Rating Scale [ Time Frame: 3 months post implant ]
  • Incidence of all serious adverse events [ Time Frame: 3 months post implant ]
Complete list of historical versions of study NCT02221934 on ClinicalTrials.gov Archive Site
  • Secondary Effectiveness: Pain Relief after 2 hours [ Time Frame: 12 months post implant ]
    Average percent change of pain intensity from before treatment, 30 minutes post treatment, and 2 hours post treatment
  • Secondary Effectiveness: Pain Days per Week [ Time Frame: 12 months post implant ]
    Average number of pain days compared at Month 3, Month 6 and Month 12 to Baseline.
  • Secondary Effectiveness: Pain Medication Use [ Time Frame: 12 months post implant ]
    Average morphine equivalent dose per day over two weeks compared at Month 3, Month 6 and Month 12 to Baseline.
  • Secondary Effectiveness: Pain Interference to Activities of Daily Living (ADL [ Time Frame: 12 months post implant ]
    Brief Pain Inventory summary score compared at Month 3, Month 6 and Month 12 to Baseline.
  • Secondary Effectiveness: Health-related quality of life (HR-QOL) [ Time Frame: 12 months post implant ]
    EQ-5D summary index, SF-12 physical component and mental component summary compared at Month 3, Month 6 and Month 12 to Baseline.
  • Secondary Effectiveness: Patient Global Impression of Change (PGIC) [ Time Frame: 12 months post implant ]
    Comparison of Patient Global Impression of Change across the Month 3, Month 6 and Month 12 office visits
  • Secondary Safety [ Time Frame: 12 months post implant ]
    Incidence of all Non-Serious Adverse Events, including Non-Serious Adverse Events, Non-Serious Adverse Device Events, and Unanticipated (Non-Serious) Adverse Device Events from the time of consent through 12 months post implant.
  • Pain Medication Use [ Time Frame: 12 months post implant ]
  • Pain interference to Activities of Daily Living (ADL) [ Time Frame: 12 months post implant ]
  • Health-related quality of life (HR-QOL) [ Time Frame: 12 months post implant ]
Exploratory Efficacy: Prosthetic Use [ Time Frame: 12 months post implant ]
Average hours of prosthetic use per week averaged across two weeks compared at Month 3, Month 6 and Month 12 to Baseline.
Not Provided
 
Electrical Nerve Block for Amputation Pain
High-Frequency Nerve Block for Post-Amputation Pain: A Pivotal Study
The purpose of the clinical trial is to learn whether electrical nerve block via the Altius System is a safe and effective treatment for patients with post-amputation pain.
The Altius System is an implanted device designed to electrically block nerve signals and alleviate pain. Use of this device may be associated with providing an effective, mechanism-based yet non-destructive, treatment for managing intractable limb pain in amputees. In a given patient, the Altius System will be deemed effective if treatment results in 50% reduction of pain score for more than 50% of all pain episodes.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
  • Post-Amputation Pain
  • Phantom Limb Pain
  • Residual Limb Pain
  • Stump Pain
Device: Altius
Electrical signal
  • Experimental: Signal more likely to block nerve
    Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block
    Intervention: Device: Altius
  • Active Comparator: Signal less likely to block nerve
    Electrical signal delivered to nerve by Altius, a device designed for high-frequency nerve block
    Intervention: Device: Altius
Soin A, Shah NS, Fang ZP. High-frequency electrical nerve block for postamputation pain: a pilot study. Neuromodulation. 2015 Apr;18(3):197-205; discussion 205-6. doi: 10.1111/ner.12266. Epub 2015 Feb 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
180
130
September 2025
June 2020   (Final data collection date for primary outcome measure)

Key Inclusion Criteria:

  • Age ≥ 21 years old
  • Unilateral amputated leg ≥ 12 months
  • Chronic post amputation pain ≥ 6 months
  • Pain episodes typically lasting ≥ 60 minutes
  • Stable drug regimen ≥ 6 weeks
  • No changes to medications or prosthesis for 3-month primary study period

Key Exclusion Criteria:

  • Implanted with an active implantable medical device (i.e. pacemaker)
  • Confounding source of pain that interferes with reporting of limb pain
  • Uncontrolled diabetes
  • Spasticity preventing full range of motion of involved side
  • Extremely short stump; sits on end
  • Untreated psychological condition (i.e. borderline personality)
  • Condition requiring MRI studies or diathermy after device implant
  • Life expectance of less than 24 months
  • Progressive neurological disease (i.e. multiple sclerosis)
Sexes Eligible for Study: All
21 Years and older   (Adult, Older Adult)
No
Contact: Barbara S Lindsay blindsay@neurosmedical.com
Contact: Matt Iorio 440-951-2565 ext 121 miorio@neurosmedical.com
United States
 
 
NCT02221934
003-0001
QUEST Trial ( Other Identifier: Neuros Medical )
Yes
Not Provided
Not Provided
Neuros Medical, Inc.
Neuros Medical, Inc.
Not Provided
Principal Investigator: Leonardo Kapural, MD, PhD Center for Clinical Research, Winston-Salem NC
Neuros Medical, Inc.
May 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP